At a glance
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An Evaluation of the Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin-tract Infection in Research Participants Receiving External Fixation Following Deformity Correction and Traumatic Provisional Fixation
In Brief
A clinical study evaluating Novel Microbicidal Liquid Polymer for Infection and Post-operative Care. Completed, enrolled 13 participants across 1 site.
Detailed Summary
The purpose of the study is to investigate additional clinical uses for the polymer, which is a FDA approved, 510k, medical device, but has not been approved for use on patients with pin track sites as a way to lower the infection rate and is investigational for this purpose. The approved uses include wound care and post-operative care. About 13 subjects will take part in this study.
Study Details
Timeline
Interventions
The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.